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OpenTrials
Active, Not Recruiting

NCT Number: NCT06640335

The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying

The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre (CNRC)

Singapore, 117599

About this study

The proposed research is part of strategies to manipulate postprandial glycemia and generate weight-control-related benefits, such as promoting satiation. Literature has shown pre-loading caloric nutrients can change postprandial glycemia, but the mechanism is unclear. The investigators hypothesize that a small number of nutrients released in the small intestine can initiate physiological changes and develop feedback control to delay gastric emptying, leading to the delay in digestion of glycemic carbohydrates and the consequent moderate glycemic responses. The investigators propose to use potatoes as the testing glycemic carbohydrates, and the pre-load foods are green vegetables. The investigators will be testing the optimal preload time to achieve the highest control of glycemic response as well as the strongest effect in satiety induction. In addition, green vegetables will be consumed with or without a preload fat enhancer (canola oil) to investigate the mechanism behind significant preload compositions. Healthy adults will be instructed to eat the leafy vegetables first (with or without canola oil), followed by the potato foods (i.e., mashed potatoes). The measurement is the gastric emptying time, blood sugar concentration, insulin, and an appetite-related gut hormone GLP-1. In order to monitor gastric emptying using a non-invasive approach, a popular breath test used in children and a hydrogen breath test will be used to present the change of gastric emptying and the level of gut fermentation.

Results will demonstrate the mechanism of the impact of pre-loading nutrients on the digestion of glycemic carbohydrates. The goal is to eliminate the negative influence of glycemic carbohydrate consumption. Instead, to generate health benefits from dietary carbohydrates.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight >/= 45 kg
  • Normal blood pressure </=120/80 mmH
  • Fasting blood glucose of <5.6 mmol/l
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.

Exclusion criteria

  • Smokers.
  • Individuals with any metabolic diseases (such as diabetes, hypertension etc).
  • Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
  • Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
  • Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
  • Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug.
  • Individuals with history of malabsorption due to mucosal disease, pancreatic disease, or other causes.
  • Individuals with history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders).
  • Individuals who are allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
  • People who intentionally restrict food intake.
  • People who consume excessive 13C rich products such as corn, sugar beet and pineapple.
  • Individuals who partake in sports at the competitive and/or endurance levels
  • Individuals who have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV).
  • Individuals who is a study team member or an immediate family of any study team member.
  • Individuals who consume Excessive alcohol: consuming >/= 6 alcoholic drinks per week.

Treatment and study plan

Co-ingestion

Other

Subjects co-ingest both (300 g mashed potatoes) and (200 g baby round spinach supplemented with canola oil) in the same time.

0 min preload

Other

Subjects consume 200 g baby round spinach supplemented with canola oil first, then directly consume 300 g of mashed potatoes.

5 min preload

Other

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 5 minutes, then consume 300 g of mashed potatoes.

10 min preload

Other

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

15 min preload

Other

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 15 minutes, then consume 300 g of mashed potatoes.

20 min preload

Other

Subjects consume 200 g baby round spinach supplemented with canola oil first, wait 20 minutes, then consume 300 g of mashed potatoes.

Spinach only / 10 min preload

Other

Subjects consume 200 g baby round spinach WITHOUT canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Canola oil only / 10 min preload

Other

Subjects consume 20 g of canola oil first, wait 10 minutes, then consume 300 g of mashed potatoes.

Primary outcomes

  1. Postprandial blood glucose

    Time frame: up to 3 hour (180 minutes) after test meal consumption

    Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Glucose levels are tested in the serum using cobas c311 analyzer.

  2. Postprandial blood Insulin

    Time frame: up to 3 hour (180 minutes) after test meal consumption

    Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Insulin levels are tested in the serum using cobas e411 Immunoanalyzer.

  3. Postprandial Glucagon Like Peptide -1 Total (GLP-1)

    Time frame: up to 3 hour (180 minutes) after test meal consumption

    Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. GLP-1 levels are tested in the plasma using GLP-1 Total ELISA kit (EZGLP1T-36K)

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Collaborators

  • Alliance for Potato Research and Education

Registry information

Official study title

The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying in Healthy Adults: A Randomized Cross-over Trial

Acronym: APRE

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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